Blood samples which are to be analyzed for constituents thereof such as glucose, uric acid, cholesterol, or drugs contained in the blood, such as theophylline, digoxin and phenytoin, are often collected from a patient in vacuum tubes. These vacuum tubes often contain an inert separator gel to separate the serum or plasma collected from the blood cells upon centrifugation. After centrifugation, the blood cells are thrown to the bottom of the tube, with the serum or plasma at the top of the tube and the separator gel being between the blood cells and the serum or plasma. The stopper is then removed manually from the vacuum tube to make the serum or plasma available for analysis.
While removing the stopper from a tube, the fluid, i.e., serum or plasma, in the tube can contact the hand of the operator directly as well as indirectly from fluid droplets which may be sprayed onto the surroundings as the stopper is forced out of the tube. Once the stopper is removed, the serum or plasma is poured into sample cups which then can be manually or automatically analyzed. The blood collecting tube is then restoppered, generally manually. The analyses can be performed by pipetting an exact amount of the serum or plasma into a reagent or test system. During all of these operations, the laboratory technician must manually remove and replace the stopper of the blood collection device, which often results in contact with the fluid in the collection device.
In other procedures, whole blood is used for the determination of chemical components of the blood or for determination of blood components. In this case, there is no requirement for separating the serum or plasma from red blood cells. The blood is merely collected from the patient into a vacuum tube which generally contains an anticoagulant to prevent clotting of the blood. The whole blood is subsequently removed from the blood collection tube for analysis by any conventional means. Again, before such analysis can be performed, the blood is poured out of the tube after first manually removing the stopper and, thus, presenting the same danger of accidentally splashing fluid on the operator, as discussed above.
Devices such as filers or membranes used to separate blood, which filters or membranes are not inside of a container, are shown in U.S. Pat. No. 4,256,693 and PCT/US96/02192. U.S. Pat. No. 4,256,693, deals with a filter layer capable of separating the cellular components from the non-cellular components in the blood. U.S. application PCT/US86/02192 deals with a process for separating the chemical components from cellular components of blood using a hydrophobic membrane treated with a surfactant. These blood separation techniques are not confined inside of a closed container. In addition, the device of the present invention is not a blood separation device per se.
U.S. Pat. No. 3,771,965 discloses a fluid sample tube assembly which includes a collection tube with a closure member sealing one end of the tube. The closure is provided with a cannula needle to receive fluid directly from a patient's body. The apparatus contains movable parts which, upon the application of external force, permit the sample to be drawn inside the tube for further processing without the need for opening the tube.
U.S. Pat. No. 3,647,386 discloses a sample processing container especially for use with serum or blood samples contained in a capillary tube which allows the capillary tube to be washed and its contents properly diluted.
U.S. Pat. No. 3,277,894 discloses a syringe package for injectable fluids comprising a barrel and a plunger to deliver fluids outside of a barrel, which barrel is not sealed.
U.S. Pat. No. 4,209,488 discloses a fluid collection system which can be used for separating blood serum or plasma from blood cells and particulate matter. The apparatus comprises an elongated hollow body which is closeable at both ends with a self-sealing septum near one end.
Brignola, in U.S. Pat. No. 4,296,786, discloses a fluid transfer device having a central disc portion and elongated cannulas or spikes disposed centrally thereof. The spikes are aligned and formed integrally with the disc of a suitable plastic material and are provided with a pair of axially extending transfer passages to permit fluid flow from one container to another. The cannulas terminate in tip portions which are tapered to facilitate penetration of a rubber stopper in a collection container. The fluid passage and the air venting passage are of different diameters. Various cover members are removed prior to use.
Cavazza, in British application 2,026,992 A discloses a taping device comprising a recessed capsule provided with an axially extending cylindrical body having faces parallel to each other and cut slanted to the body to provide a piercing top on each end of the body. The piercing top includes two parallel adjacent passages wherein the opposite outlets of one passage are axially offset from the corresponding outlets of the adjacent passage. The device is carried by a peripherally extending support which is matingly received in a suitably shaped recess provided in the bottom of the hollow capsule. A container closed by a rubber plug has a neck dimensioned to be received in the recess of the capsule.
Ogle, in U.S. Pat. No. 3,941,171, discloses a fluid transfer device comprising two parallel fluid passages, both carried by a flange which is generally perpendicular to the passages, wherein the two ends of the passages on each side of the flange are longitudinally displaced from one another and a medicament container having an open end closed by a rubber stopper. Each of the fluid passages can pierce the stopper. There is no means to protect a user from the sharp tips of the conduit ends.
Finley, in U.S. Pat. No. 4,256,120, discloses an evacuated blood sample collection device disposed in a conventional tube and needle holder 12 which includes a cylindrical portion having an opened end for receiving the collection device and a closed end for carrying a needle assembly having a double-ended needle cannula. The needle is pointed at each end, extends longitudinally along the axis of the holder and has a distal end portion exterior to the holder and a proximately portion extending proximally within the cylindrical portion.